On October 6, the Office of Inspector General issued a Policy Reminder entitled “Information Blocking and the Federal Anti-Kickback Statute.” The purpose of this reminder was to ensure the public understands how information blocking can affect safe harbor protection under the Federal anti-kickback statute (42 U.S.C. 1320a-7b(b)) and to encourage the public to report any instances where a donor acts to limit the interoperability of donated EHR items or services by calling their hotline.

Information blocking is knowingly and unreasonably interfering with the exchange or use of electronic health information. It is a barrier to interoperability and health information exchange. Examples include agreements with recipients to preclude or inhibit competitors from interfacing with the donated system; agreements by vendors with donors to charge high fees to non-recipient provider or suppliers or to competitors to interface with the donated system; and arrangements where parties improperly lock in data.

The anti-kickback statute prohibits individuals and organizations from knowingly and willfully soliciting, offering, paying or receiving payment for referrals of business reimbursement under any federal healthcare program. Those who violate the anti-kickback statute face civil monetary damages, program exclusion, criminal penalties, and liability under the False Claims Act. When providers, such as hospitals, give existing or potential referral sources, such as physician practices, software or information technology, the anti-kickback statute is potentially implicated.

The federal government seeks to enable an interoperable learning health system, meaning that information and data can be shared between the many players in the health care system such as clinicians, labs, hospitals, pharmacies and patients, regardless of the application or application vendor. Such a system in which information can be securely and efficiently shared would support patient-centered care, enhance health care quality and efficiency, and advance research and public health. To further this goal, the Office of the National Coordinator for Health Information Technology, (ONC) has spent more than $28 billion in incentive payments to encourage health care professionals and hospitals to adopt and use electronic health records (EHRs) under the Health Information technology for Economic and Clinical Health (HITECH) Act.

To remove barriers blocking the adoption of EHRs, OIG has granted safe harbor protection to some arrangements involving donations of interoperable EHR items and services to potential referral sources (42 C.F.R. § 1001.952(y)). The statute imposes several requirements that must be met. One such requirement is that if the donor engages in information blocking by taking any actions that limit or restrict the use, compatibility, or interoperability of the donated EHR items or service, the safe harbor will not provide protection for the donor’s arrangement, and the arrangement will be exposed to liability under the anti-kickback statute. This requirement of the safe harbor poses problems both for the enforcing body and for the regulated industry.

One issue is how the government can determine whether information blocking is happening. Successful strategies to prevent information blocking will likely require congressional intervention. In a report for Congress on health information blocking written in April 2015, ONC wrote that their ability to target and deter information blocking is limited. For example, ONC lacks access to detailed price and cost data, contract language, technical documentation and other evidence that would allow it to determine whether the conduct of complained of parties meets the definition of information blocking, and their ability to require disclosure of such data is limited. This limitation severely undercuts ONC’s ability to enforce the information blocking requirement of the EHR safe harbor.

An additional issue is how to take into account the countervailing interests to prohibiting information blocking. Controlling the exchange of electronic health information can be beneficial in that it helps to protect patient privacy, security and safety, promotes competition among health care providers, and promotes investment and innovation in development of more effective health IT. Therefore, there are significant economic and health interests in not cracking down on information blocking.

In light of these issues, it is clear that action must be taken to promote efficient enforcement of the information blocking requirement of the EHR safe harbor while maintaining the economic interests of the health care industry and the provision of effective health care services. One solution could be to increase the transparency of the health care industry with regard to HER items and services. Another solution could be for Congress to intervene.  Either way, a solution is urgently needed in light of the repercussions of losing safe harbor protection for health care providers.

Amelia Montgomery

 

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